Invossa was sold even after error discoveredKolon Life Science continued to sell a gene therapy even after it knew there was a serious problem with it.
The regulator is also being criticized for not moving quickly once it knew that the treatment was not exactly what it was supposed to be.
According to data acquired by Democratic Party Rep. Jeong Choon-sook from the Korean regulator on Monday, 324 units of Invossa, which was developed to treat arthritis of the knee, were sold even after its manufacturer became aware that the gene therapy was made using the wrong type of cells.
The data show that a Kolon Life subsidiary became aware of the presence of kidney cells in the therapy on Feb. 26; Invossa was approved on the basis that it was made with cartilage cells.
Kolon Life Science CEO Lee Woo-suk was notified of the error by Kolon TissueGene, a U.S. subsidiary, over the phone on that date, and the company received a detailed report by email on March 4.
The presence of kidney cells is a potential health hazard, as the errant cells could cause tumors. Kolon Life Science has been downplaying the risk, as it uses radiation on Invossa to prevent cells from multiplying out of control.
Kolon Life Science only reported the information to the Ministry of Food and Drug Safety on March 22, almost a month after the company initially became aware of the problem.
The drug remained on the shelves in Korea until March 31, which is when the distribution and sale of the problematic gene therapy was suspended.
Between knowing about the problem and pulling the medicine from the market, 324 units of the injectable gene therapy drug were sold in Korea.
The timeline also shows that the Ministry of Food and Drug Safety failed to act promptly on the information and left patients potentially exposed to a possible health hazard. The data show that the Korean regulator only held a meeting on the matter on March 31.
The Ministry of Food and Drug Safety officially revoked the license for Invossa on July 3, after starting the formal process on May 28. The regulator received a detailed analysis of Invossa on March 29.
As clinical trials for Invossa in the United States are now all but impossible, Kolon Life Science is looking for other ways to make profit. The U.S. Food and Drug Administration rejected Kolon TissueGene’s request to resume Phase 3 clinical trials for Invossa earlier this month.
Kolon Life Science said Monday that it has signed a contract manufacturing deal with SL Bigen, a local Korea company, to produce BM102, a hypoxic-ischemic encephalopathy treatment candidate, until December 2022 ahead of Phase 1 clinical trials of the drug.
The agreement marks Kolon Life Science’s first step into the contract manufacturing business.
It is using its factory in Chungju, North Chungcheong, which has remained virtually idle since the company was stopped from manufacturing Invossa.
BY KO JUN-TAE [email@example.com]